[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 449 Introduced in House (IH)]







104th CONGRESS
  2d Session
H. RES. 449

  Relating to breast implants, the Food and Drug Administration, and 
                              breast care.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 1996

 Mrs. Vucanovich (for herself, Mr. Calvert, Mrs. Clayton, Mr. Hobson, 
Mr. Hutchinson, Mrs. Johnson of Connecticut, Mr. Lipinski, Mr. Myers of 
 Indiana, Mr. Petri, and Mr. Wamp) submitted the following resolution; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                               RESOLUTION


 
  Relating to breast implants, the Food and Drug Administration, and 
                              breast care.

Whereas breast implant safety is a public health issue of fundamental 
        importance, particularly for those women who already have implants and 
        women who are diagnosed with breast cancer facing urgent decisions about 
        reconstruction;
Whereas manufacturers of silicone breast implants are encouraged to pursue the 
        premarket approval application process with the Food and Drug 
        Administration;
Whereas conflicting information has been provided to the public about the safety 
        of silicone gel breast implants;
Whereas the Food and Drug Administration imposed restrictions on the 
        availability and use of breast implants, based on concerns of a possible 
        relationship between silicone gel breast implants and connective tissue 
        disease;
Whereas breast cancer patients seeking reconstruction may only gain access to 
        silicone gel breast implants through participation in a clinical trial 
        under an approved protocol;
Whereas only a small fraction of the post-mastectomy patients in the United 
        States who seek reconstruction have access to silicone gel breast 
        implants through clinical trials;
Whereas research has been undertaken by many prestigious medical centers and 
        universities on the issue of silicone gel breast implants and connective 
        tissue disease;
Whereas controlled scientific studies conducted by these prestigious 
        universities to date show no greater incidence of connective tissue 
        disease in women with implants than those without;
Whereas the Food and Drug Administration has not issued a definitive statement 
        on the relationship between silicone gel breast implants and connective 
        tissue disease;
Whereas the Food and Drug Administration has not provided substantial 
        information on breast care for women with implants;
Whereas the National Cancer Institute has not provided substantial information 
        on breast care for women with implants, waiting for the Food and Drug 
        Administration's lead in this matter; and
Whereas the controversy over silicone gel breast implants has a broader impact 
        on the public health by adversely affecting the supply of raw materials 
        used in other products, such as pacemakers, heart valves, hip and knee 
        joints, and artificial blood vessels: Now, therefore, be it
    Resolved, That it is the sense of the House of Representatives that 
the Food and Drug Administration should take immediate steps to resolve 
the fears and concerns of women with breast cancer by issuing a 
definitive statement on the relationship (or lack thereof) between 
silicone gel breast implants and connective tissue disease, classic 
auto-immune symptoms, and other serious diseases. In addition, the Food 
and Drug Administration and the National Cancer Institute should 
develop recommendations for breast care practices for women with breast 
implants.
                                 <all>